FDA UDI
In Commercial Distribution
🇺🇸 United States
osseolink Implant
DI: 00816273020580
·
Model: STD40
·
OSSEOLINK USA LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- osseolink Implant
- Primary DI
- 00816273020580
- Version / Model
- STD40
- Company Name
- OSSEOLINK USA LLC
- Labeler DUNS
- 080083007
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-18
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- d420de0c-a7b8-4494-b07a-cd7c8469a95d
Device Description
Step Drill ø 4.0 mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31823 | Dental drilling system attachment | A device, e.g., a straight, contra-angle or right-angle attachment, that is connected to a drill handpiece to achieve a specific function such as accessing intraoral areas that are difficult to reach when cleaning teeth, or preparing dental cavities for restorations (e.g., fillings) or preparing teeth for crowns and bridges. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816273020580 | GS1 |
Customer Contacts
- Phone
- +1(877)677-3688
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091878 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 4 | Millimeter | |
| Device Size Text, specify | Step Drill ø 4.0 mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight